Coronary Artery DiseaseNCT04011527
The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s
An observational study of Coronary Artery Disease, run by Segeberger Kliniken GmbH at 1 site in Germany.
Trial summary
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rotational Atherectomy in Coronary Lesion/s
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- 25 Nov 2002to 31 Dec 2032
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease undergoing a rotational atherectomy in coronary lesion/s
Who may be able to join
- All patients undergoing a rotational atherectomy of coronary lesion/s
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Herzzentrum Segeberger Kliniken GmbH
Bad Segeberg, 23795
Gert Richardt, MD, +49 4551 802 4801, gert.richardt@segebergerkliniken.de
About this study
Official title: A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing a Rotational Atherectomy in Coronary Lesion/s
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s
Read the detailed description
A prospective single center registry including all patients treated with Rotational Atherectomy in Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.
- Conditions
- Coronary Artery Disease
- Being tested
- Rotational Atherectomy in Coronary Lesion/s
- Keywords
- Calcified coronary artery lesions
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational Atherectomy in Coronary Lesion/sProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with Coronary Artery Disease | Patients with Coronary Artery Disease undergoing a Rotational Atherectomy in Coronary Lesion/s Receives: Procedure: Rotational Atherectomy in Coronary Lesion/s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of in-hospital and long-term cardiovascular adverse events in percent
Peri-procedural events and in-hospital cardiovascular events and long-term cardiovascular events (bleeding, peripheral and coronary vascular complication, stroke, myocardial infarction, stent thrombosis, revascularization, death)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start25 Nov 2002
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Segeberger Kliniken GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gert Richardt, Prof., MD, Study director, Herzzentrum Segeberger Kliniken GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011527
- Sponsor's protocol ID
- SK 111 -- 168/11
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2019
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No